Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction

Not Applicable

• Conditions: Posterior Crossbite
• Interventions: Procedure: microosteoperforation; Device: tooth borne hyrax expander

• Registration Number: NCT03772379
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.

Detailed Description

The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.

Study Timeline

• Study First Submitted: 2018-11-27
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-10
• Last Update Submitted: 2018-12-10
• Study First Posted: 2018-12-11
• Last Update Posted: 2018-12-11
• Study Start: 2019-02
• Primary Completion: 2020-02
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

• Female adolescent patients with an age range 11- 14 years.
• Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
• Normal vertical growth pattern.
• Fully erupted maxillary first premolars and first permanent molars.

Exclusion Criteria

• Previous orthodontic treatment.
• Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
• Active periodontal affection or severe gingival inflammation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tooth borne hyrax expander with microosteoperforation	microosteoperforation	patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .
tooth borne hyrax expander group	tooth borne hyrax expander	patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .

Primary Outcome Measures

Name	Time	Method
Alveolar bending	an average1 year	it will be measured in degree on Cone beam computed tomography image using a software
Dental changes(transverse).	an average1 year	it will be measured in mm on Cone beam computed tomography image using a software
Dental tipping.	an average1 year	it will be measured in degree on Cone beam computed tomography image using a software
Skeletal changes(transverse, anteroposterior and vertical)	an average1 year	it will be measured in mm on Cone beam computed tomography image using a software

Secondary Outcome Measures

Name	Time	Method
Pattern of expansion	an average1 year	it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.